BACKGROUND New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation. METHODS AND RESULTS In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P,0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no ...
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OBJECTIVES: The purpose of the present study was to test whether the cumulative knowledge from the field of transapical transcatheter aortic valve implantation, when incorporated into a structured training and then gradually dispersed by internal proctoring, might eliminate the negative effect of the learning curve on the clinical outcomes. METHODS: The present study was a retrospective, single-center, observational cohort study of prospectively collected data from all 500 consecutive high-risk patients undergoing transapical transcatheter aortic valve implantation at our institution from April 2008 to December 2011. Of the 500 patients, 28 were in cardiogenic shock. Differences during the study period in baseline characteristics, procedural and postprocedural variables, and survival were analyzed using different statistical methods, including cumulative sum charts. RESULTS: The overall 30-day mortality was 4.6% (95% confidence interval, 3.1%-6.8%) and was 4.0% (95% confidence interval, ...
TY - JOUR. T1 - Comparison of midterm outcomes of transcatheter aortic valve implantation in patients with and without previous coronary artery bypass grafting. AU - On behalf of the OCEAN-TAVI Investigators. AU - Kawashima, Hideyuki. AU - Watanabe, Yusuke. AU - Kozuma, Ken. AU - Kataoka, Akihisa. AU - Nakashima, Makoto. AU - Hioki, Hirofumi. AU - Nagura, Fukuko. AU - Nara, Yugo. AU - Shirai, Shinichi. AU - Tada, Norio. AU - Araki, Motoharu. AU - Naganuma, Toru. AU - Yamanaka, Futoshi. AU - Ueno, Hiroshi. AU - Tabata, Minoru. AU - Mizutani, Kazuki. AU - Higashimori, Akihiro. AU - Takagi, Kensuke. AU - Yamamoto, Masanori. AU - Hayashida, Kentaro. PY - 2018/4/21. Y1 - 2018/4/21. N2 - The midterm safety and feasibility of transcatheter aortic valve implantation (TAVI) for patients with a history of coronary artery bypass graft (CABG) and high operative risk are unclear. This study compared the midterm outcomes of patients undergoing TAVI with or without previous CABG surgery. Between October 2013 ...
Introduction Permanent pacemaker implantation (PPM) following transcatheter aortic valve implantation (TAVI) is a recognised complication. However, the higher pacing rate post CoreValve TAVI compared to SAVR (33% vs 8%) is a cause for concern. Several factors including pre-existing bundle branch block (BBB), larger valve size, post dilatation and low implantation have been shown to independently impact on an increased risk of PPM requirement. Depth of CoreValve implantation below the aortic annulus can result in compression of conduction tissue and heart block and is therefore an important predictor of PPM requirement. A modified delivery catheter (ACCUTRAK) was introduced to address this by providing more controlled release of the prosthesis, preventing low implantation, thereby reducing the pacing rate. We evaluated the pacing rate in our cohort of patients (pts) and the effect of the new Accutrak catheter on the pacing rate. ...
Vascular complications were a factor that tempered the enthusiasm of widespread adoption of transcatheter aortic valve replacement (TAVR) after the completion of the original PARTNER IB (The Placement of Aortic Transcatheter Valves IB) trial (1). In that trial, the rate of major vascular complications was 16.2%. This was not surprising given the need for a 22- or 24-F delivery sheath via a transfemoral approach only. This rate later decreased in a high risk cohort of patients (2). This was not only as a result of increased operator experience, but also because of the availability of an alternative access for patients with peripheral arterial disease. The transapical approach involved direct left ventricular puncture with placement of a 26-F delivery sheath, which allowed delivery of the valve. As TAVR became available commercially, additional access approaches were developed. The first of these, the transaortic approach, showed lower rates of combined bleeding and vascular events compared to a ...
A prospective multi-center trial of patients undergoing aortic valve replacement for severe aortic stenosis. Patient cohorts will include the following groups based on operative risk for surgical aortic valve replacement: inoperable, high surgical risk (STS ≥ 8%), and intermediate risk (STS = 4-8%).. The Edwards SAPIEN XT transcatheter heart valve (THV) system will be studied in patients deemed inoperable or intermediate risk. A subset of inoperable patients will be randomized to receive transcatheter aortic valve replacement (TAVR) with either the SAPIEN XT THV or the SAPIEN THV. The SAPIEN XT will be studied in intermediate risk patients randomized to receive TAVR with the SAPIEN XT or surgical AVR.. The Edwards SAPIEN 3 THV will be studied in a non-randomized fashion in patients from all three risk groups.. Data will be collected from all patients for up to five years following the valve replacement procedure. ...
A prospective multi-center trial of patients undergoing aortic valve replacement for severe aortic stenosis. Patient cohorts will include the following groups based on operative risk for surgical aortic valve replacement: inoperable, high surgical risk (STS ≥ 8%), and intermediate risk (STS = 4-8%).. The Edwards SAPIEN XT transcatheter heart valve (THV) system will be studied in patients deemed inoperable or intermediate risk. A subset of inoperable patients will be randomized to receive transcatheter aortic valve replacement (TAVR) with either the SAPIEN XT THV or the SAPIEN THV. The SAPIEN XT will be studied in intermediate risk patients randomized to receive TAVR with the SAPIEN XT or surgical AVR.. The Edwards SAPIEN 3 THV will be studied in a non-randomized fashion in patients from all three risk groups.. Data will be collected from all patients for up to five years following the valve replacement procedure. ...
Introduction: Readmission within 30 days of hospitalization (30dRA) is increasingly used as a metric for quality of care. Transcatheter aortic valve replacement (TAVR) is also increasing, but 30dRA following TAVR is not well-understood.. Hypothesis: The purpose of this study is to define the incidence, etiology, and resource utilization of 30dRA following TAVR.. Methods: We used the ICD-9-CM code for TAVR (35.05) to identify patients who underwent TAVR and survived to discharge in 2012, in the Agency for Healthcare Research and Qualitys Healthcare Cost and Utilization Projects State Independent Databases for 4 geographically distinct states: Florida, Massachusetts, New York, and Washington. The patients were divided into 2 groups: those with and without a 30dRA. Patients with a 30dRA for rehabilitation on the day of discharge were excluded. Approximately 8% of 30dRA were not captured because they occurred in the following year.. Results: The incidence of 30dRA following TAVR was 20.2% ...
The most frequent mechanism associated with coronary obstruction after TAVI has been the displacement of the calcified native cusp over the coronary ostium, and this has also been confirmed by the present review of the published data. In fact, no cases of coronary obstruction related to the struts of the transcatheter valve frame or to the cuff/leaflets of the transcatheter valve itself have been reported to date. Although the final mechanism leading to coronary obstruction after TAVI is well understood, the risk factors that predispose a patient to its occurrence remain largely unknown. A low position of the coronary ostia with respect to the aortic annulus has been highlighted as one of the most important factors contributing to this complication, and it has been suggested that a coronary ostia height cutoff ≤10 mm increases the risk of coronary obstruction during TAVI (41,42). In a recent post-mortem study, including 51 normal hearts, the mean LCA height, as determined by the LCA distance ...
OBJECTIVES: The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting.. BACKGROUND: Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath.. METHODS: The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure.. RESULTS: The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary ...
The first-in-human transcatheter aortic valve implantation (TAVI) was successfully performed in 2002. In excess of 50,000 TAVI procedures have been performed to date using the Edwards SAPIEN or...
Advanced chronic kidney disease (CKD) is an independent predictor of mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to identify predictors of 1-year mortality in patients after TAVI stratified by the presence or absence of advanced CKD (defined as estimated glomerular filtration rate ≤30 ml/min/1.73 m2 or permanent renal replacement therapy). Patients (n = 1204) from 10 centers in Europe, Japan, and Israel were included: 464 with and 740 without advanced CKD. Advanced CKD was associated with a 2-fold increase in the adjusted risk of 1-year all-cause death (p |0.001), and a 1.9-fold increase in cardiovascular death (p = 0.016). Interaction-term analysis was used to identify and compare independent predictors of 1-year mortality in both groups. Impaired left ventricular ejection fraction and poor functional class were predictive of death in the advanced CKD group (odds ratio [OR] 2.27, p = 0.002 and OR 3.87, p = 0.003, respectively) but not in patients without
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe,...
David H. Adams, MD, national co-principal investigator for the CoreValve U.S. Pivotal Trial, presented study results showing minimally invasive transcatheter aortic valve replacement (TAVR) with the CoreValve System is superior to surgical aortic valve replacement (SAVR) at one year in patients with severe aortic stenosis who are considered high risk for surgery.. Dr. Adams presented the findings at a late-breaking clinical trial session at the 63rd Annual Scientific Session of the American College of Cardiology (ACC), and also published simultaneously in the New England Journal of Medicine (NEJM).. The CoreValve High Risk Study is the first prospective, randomized study to show any transcatheter aortic valve to be superior to surgery. The CoreValve System was approved by the U.S. Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk for surgery; the device is not currently approved in the U.S. for use with patients at high risk.. The head-to-head study met its ...
Philip F, Wong GB, Rogers JH, Low RI, Southard JA. Aortic Root and Annular Anatomical Exclusion for Transcatheter Aortic Valve Implantation. TCT Scientific Sessions. San Francisco, CA. November 11-15, 2015.. Wong GB, Southard JA, Rogers JH, Smith TW, Philip F, Singh G, Latif S, Boyd WD, Atkins B, Low RI. Heart Rate Variability of the Aortic Regurgitation Index Following Transcatheter Aortic Valve Replacement. SCAI 2015 Scientific Sessions. San Diego, CA May 6-10, 2015.. Sarcon A, Ghadri JR, Wong GB, Luscher TF, Templin C, Amsterdam EA. Takotsubo cardiomyopathy associated with opiate withdrawal. Q J Med. 2014; 107: 301-302.. Singh GD, Wong GB, Southard JA, Amsterdam EA. Food for thought: Atrioventricular dissociation. Am J of Medicine. 2013; 126(12): 1050-1053.. Wong GB, Southard J, Rogers J, Singh G, Smith T, Armstrong E, Flores M, Boyd D, Low R. Heart Rate Variability of the Aortic Regurgitation Index Following Transcatheter Aortic Valve Replacement. SCAI 2013 Scientific Sessions. Orlando, FL ...
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We sought to analyze outcomes of women receiving balloon-expandable valves (BEV) or self-expanding valves (SEV) in contemporary transcatheter aortic valve implantation (TAVI). WIN TAVI (Womens INternational Transcatheter Aortic Valve Implantation) is the first all-female TAVI registry to study the safety and performance of TAVI in women. We compared women treated with BEV (n = 408, 46.9%) versus those treated with SEV (n = 461, 53.1%). The primary efficacy end point was the Valve Academic Research Consortium-2 (VARC-2) composite of 1-year all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction. Women receiving SEV had higher surgical risk scores, higher rate of previous stroke and pulmonary hypertension whereas women receiving BEV were more frequently denied surgical valve replacement due to frailty. BEV patients were less likely to require post-dilation and had significantly lower rates of residual aortic ...
Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for inoperable or surgical high-risk patients with severe aortic stenosis (1-3). Post-procedural aortic regurgitation (PAR) is a common complication after TAVR. PAR has been reported in 65% to 96% of TAVR cases (1,4-7). In most cases, the grade of regurgitation is usually only mild. However, moderate and severe grades of PAR occur in 2% to 24% of patients (1,4-7). Multiple studies have demonstrated that moderate and severe grades of PAR are associated with worse clinical outcomes (4,6). Furthermore, the 2-year follow-up of the PARTNER (Placement of Aortic Transcatheter Valves) trial has suggested that even mild paravalvular regurgitation has been associated with increased mortality (3). However, reliable methods to diagnose PAR severity have not been established.. The aortic regurgitation (AR) index is 1 of the valuable prognostic parameters for PAR in a catheterization laboratory (8). However, ...
RESULTS: Valve-in-valve procedures were performed in 365 patients (96 initial registry, 269 continued access patients). Mean age was 78.9 ± 10.2 years, and mean Society of Thoracic Surgeons score was 9.1 ± 4.7%. At 30 days, all-cause mortality was 2.7%, stroke was 2.7%, major vascular complication was 4.1%, conversion to surgery was 0.6%, coronary occlusion was 0.8%, and new pacemaker insertion was 1.9%. One-year all-cause mortality was 12.4%. Mortality fell from the initial registry to the subsequent continued access registry, both at 30 days (8.2% vs. 0.7%, respectively; p = 0.0001) and at 1 year (19.7% vs. 9.8%, respectively; p = 0.006). At 1 year, mean gradient was 17.6 mm Hg, and effective orifice area was 1.16 cm(2), with greater than mild paravalvular regurgitation of 1.9%. Left ventricular ejection fraction increased (50.6% to 54.2%), and mass index decreased (135.7 to 117.6 g/m(2)), with reductions in both mitral (34.9% vs. 12.7%) and tricuspid (31.8% vs. 21.2%) moderate or severe ...
Methods and Results-This multicenter, propensity score-matched study compared hemodynamics and early clinical outcomes in 246 patients with an aortic annulus area ,400 mm2 undergoing transcatheter aortic valve replacement with either a self-expanding transcatheter heart valve (Symetis ACURATE neo, n=129) or a balloon-expandable transcatheter heart valve (Edwards SAPIEN 3, n=117). The 1:1 propensity score matching resulted in 92 matched pairs. For ACURATE neo versus SAPIEN 3-treated patients, 30-day mortality (0.0% versus 1.0%), 1-year mortality (8.3% versus 13.3%), incidence of stroke (3.3% versus 2.2%), life-threatening bleeding (1.1% versus 1.1%), and major vascular complications (2.2% versus 6.5%), as well as pacemaker implantation rate (12.0% versus 15.2%), were similar. Paravalvular regurgitation ≥moderate was rare in both groups (4.5% versus 3.6%). The ACURATE neo presented lower mean transvalvular gradients (9.3 versus 14.5 mm Hg; P,0.001), larger indexed effective orifice areas (0.96 ...
Transcatheter heart valve implantation techniques recently have been developed. The basic principle is based on fixation of a pericardial xenograft in a low-profile nitinol or steel stent that can be crimped onto a catheter. Because of the low profile of the stent, excellent hemodynamic function of these devices may be achieved. Access to the heart is gained by using a transfemoral or a transapical approach. Experimental studies on different approaches have been performed (5,6), and clinical feasibility studies in selected high-risk patients have been conducted (7-9). Recently the concept of transcatheter transapical aortic valve implantation has been proven clinically (10).. All of these nonconventional approaches aim at treating high-risk patients with degenerative valve disease. To minimize the reoperative risk for failed xenografts, the VinV concept was developed. This VinV concept takes advantage of recently developed transcatheter valve implantation techniques as well as clinical ...
Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); THV dislodgement necessitated valve-in-valve implantation in one patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, two patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.. ...
Although the original VARC standardized endpoint definitions were fundamentally useful and have been widely adopted, growing experience with TAVI studies has identified some definitions as ambiguous, of limited clinical utility, or in need of updating or extension (5,6,63,64). This need provided the rationale for a VARC-2 document with such improvements and additions. As was the case with the original VARC process, it should be emphasized that this consensus manuscript is not intended to be a guidelines document, but rather a practical tool to facilitate and inform clinical research in TAVI.. Current clinical trials are focusing more on intermediate risk patients, and more studies are comparing TAVI with surgical AVR. Therefore, it becomes increasingly important to identify those patients who benefit from either treatment. Specific risk categories have been defined to allow universal clinical study designs and outcome comparisons.. Changes and additions that have been applied to improve the ...
Transcatheter aortic valve replacement (TAVR) is increasingly performed in patients who are at high surgical risk for surgical aortic valve replacement. The frequency of coronary artery disease is as high as 70 percent in patients with severe aortic stenosis. It is routine practice to perform preoperative coronary angiography and PCI in patients for whom TAVR is planned. However, many patients require post-TAVR coronary angiography and intervention. Depending on the type of the percutaneous valve, this may not be as easy as it is in the absence of a percutaneous valve. In this tip of the month, we discuss nuances and tips and tricks that can be employed for coronary angiography in these patients ...
At a median follow-up of 183 days (63-365) and 144 days (56-365), 50 patients (22%) died and 75 patients (33%) experienced MACE. A threefold increase in the rates for death and MACE was observed in patients above the median (M2 vs. M1) of CA125 (5.2 vs. 1.6 per 10 person-years and 8.3 vs. 3.3 per 10 person-years, respectively; p for both < 0.001). In a multivariable analysis adjusted for logistic EuroSCORE, New York Heart Association (NYHA) functional class III/IV, and device success, baseline values of CA125 (M2 vs. M1) independently predicted death (hazard ratio [HR], 2.18; 95% confidence interval [CI], 1.11-4.26; p = 0.023) and MACE (HR, 1.77; 95% CI, 1.05-2.98; p = 0.031). In the longitudinal analysis, InCA125 as a time-varying exposure, was highly associated with both endpoints: HR, 1.47; 95% CI, 1.01-2.14; p = 0.043 and HR, 2.26; 95% CI, 1.28-3.98; p = 0.005, for death and MACE, respectively. ...
There has been a lot of conjecture that transcatheter aortic valve replacement (TAVR) may one day replace open-heart surgical aortic valve replacement (SAVR). However, after attending the American College of Cardiology (ACC) 2016 meeting, it is evident that change will come much sooner than anyone anticipated. "Wow" is really the key summary I can offer regarding the TAVR vs. SAVR data presented at ACC. Three key presentations were all positive for TAVR, showing it is at least equal or superior to surgery. This is not bad for a new technology with largely inexperienced operators being able to perform as well or better than cardiac surgeons with decades of experience.. The Partner 2A trial for the Sapien XT showed that the second-generation TAVR device was equal to surgery in intermediate-risk surgical patients. It was pointed out by experts in numerous ACC sessions that if the two techniques are equal, the minimally invasive method will usually win out as a new standard of care. The improved ...
Background: The presence of mitral regurgitation (MR) is an independent predictor of mortality after conventional aortic valve replacement for aortic stenosis. The predictive value of pre-procedural MR on clinical outcome after TAVI is unknown.. Methods: 3,195 consecutive patients were enrolled between January 2010 and October 2011 in 33 centres. MR was graded according to pre-procedural transthoracic echocardiography (TTE) as none/trivial (=0), mild (=1), moderate (=2), moderate-to-severe (=3), or severe (=4). The mean age was 82±7 years; 49% were female and mean logistic EuroSCORE was 21.9±14.3. Balloon (BE) and self-expendable (SE) devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were transarterial (transfemoral: 74.6%; subclavian: 5.8%), transapical (17.8%), and transaortic (1.8%).. Results: Pre-procedural TTE showed no MR in 32% of cases, a grade 1 MR in 46% of cases, a grade 2 MR in 20% of cases and a grade 3-4 in 2% of cases. Procedural success rate was ...
Edwards Lifesciences Corp. said it invested $35 million to gain an exclusive right to buy privately held Corvia Medical Inc., which makes implants to treat heart failure. Tewksbury, Mass.-based Corvias InterAtrial Shunt Device is approved in the European Union to treat heart failure with preserved or mildly reduced ejection fraction. The device is undergoing clinical trials in the U.S. to seek approval from the U.S. Food and Drug Administration. Irvine, Calif.-based Edwards Lifesciences also acquired certain assets of Mitralign Inc. including intellectual property and associated clinical and regulatory experience.. Tewksbury, Mass.-based Mitralign makes devices to treat functional mitral and tricuspid regurgitation, which are diseases resulting from dysfunctional valves within the heart. Edwards Lifesciences, which is focused on making medical devices for heart diseases, did not disclose additional terms of the transactions. The company added that the transactions are not expected to impact its ...
Learn about the percutaneous valve treatments offered at MedStar Heart & Vascular Institute, including transcatheter aortic valve replacement (TAVR).
Background and purpose: Transapical aortic valve replacement (TAVR) is a recent minimally invasive surgical treatment technique for elderly and high-risk patients with severe aortic stenosis. In this paper,a simple and accurate image-based method is introduced to aid the intra-operative guidance of TAVR procedure under 2-D X-ray fluoroscopy. Methods: The proposed method fuses a 3-D aortic mesh model and anatomical valve landmarks with live 2-D fluoroscopic images. The 3-D aortic mesh model and landmarks are reconstructed from interventional X-ray C-arm CT system, and a target area for valve implantation is automatically estimated using these aortic mesh models.Based on template-based tracking approach, the overlay of visualized 3-D aortic mesh model, land-marks and target area of implantation is updated onto fluoroscopic images by approximating the aortic root motion from a pigtail catheter motion without contrast agent. Also, a rigid intensity-based registration algorithm is used to track ...
Background and purpose: Transapical aortic valve replacement (TAVR) is a recent minimally invasive surgical treatment technique for elderly and high-risk patients with severe aortic stenosis. In this paper,a simple and accurate image-based method is introduced to aid the intra-operative guidance of TAVR procedure under 2-D X-ray fluoroscopy. Methods: The proposed method fuses a 3-D aortic mesh model and anatomical valve landmarks with live 2-D fluoroscopic images. The 3-D aortic mesh model and landmarks are reconstructed from interventional X-ray C-arm CT system, and a target area for valve implantation is automatically estimated using these aortic mesh models.Based on template-based tracking approach, the overlay of visualized 3-D aortic mesh model, land-marks and target area of implantation is updated onto fluoroscopic images by approximating the aortic root motion from a pigtail catheter motion without contrast agent. Also, a rigid intensity-based registration algorithm is used to track ...
OBJECTIVES: The lower limit of the membranous septum (MS) is considered an anatomic landmark for the emergence of the Bundle of His into the left ventricle. Computed tomography (CT) assessment of MS anatomy may provide useful information about the risk of conduction abnormalities following transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: The study included 102 consecutive patients undergoing TAVR with the Edwards Sapien 3 (S3) valve. Using pre-TAVR CT and post-procedure angiography we evaluated for the presence of calcium in the left ventricular outflow tract (LVOT), calcium depth (CD), implantation depth (ID) and MS length ...
Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Department of Thoracic and Vascular Surgery. ...
Second-generation prostheses have been specifically designed to be anatomically oriented, in order to facilitate their positioning and avoid paravalvular leaks. The objective was not fulfilled here, which underlines the imperative necessity for a careful and continued evaluation of these new devices before generalizing their utilization in routine clinical practice. More generally, most of the recent international Cardiology meetings and congresses have been marked by the presentation of a large number of novel transcatheter valves, supposed to offer substantial advantages over the currently commercialized SAPIEN and CoreValve prostheses. This traduces the vitality of research and technological innovation in this field, which of course is great and should be encouraged. However, one should keep in mind the priceless favor done by the SAPIEN and the CoreValve prostheses in more than 100,000 patients during the last decade, and that new devices have yet to prove themselves ...
PARIS, May 17, 2016 /PRNewswire/ -- Edwards SAPIEN 3 Transcatheter Valve Demonstrates Positive Patient Outcomes At 30 Days In European Real-World...
RESULTS The STS score and EuroSCORE II (r = 0.504, P , 0.001) showed a good correlation, while a strong correlation was found between the logistic EuroSCORE and EuroSCORE II (r = 0.717, P , 0.001). Thirty-day and in-hospital mortality rates were 10.6% (38 of 360) and 11.4% (41 of 360), respectively. In-hospital mortality rate was estimated by the logistic EuroSCORE: 30.0 ± 15.7%, the STS score: 11.7 ± 7.8% and the EuroSCORE II: 6.7 ± 5.1%. The prognostic values of the STS score, logistic EuroSCORE and the recent EuroSCORE II systems were analysed by ROC curve analysis for the prediction of 30-day (area under the curve, AUC: 0.64 vs 0.55 vs 0.50) and in-hospital mortality (AUC: 0.65 vs 0.54 vs 0.49). Multivariate regression analysis revealed length of preoperative hospital stay ,5 days, body weight ,65 kg, preoperative aortic annular diameter ≤20 mm, vital capacity ,70% and concomitant mitral regurgitation ,1+ as independent risk factors ...
Information for Referring Doctors for THV. Information for doctors who want to refer patient who have significant valvular disease and is suitable for Transcatheter Valve Implantation. THV Referral Refer if your patient has significant valvular disease and is suitable for Transcatheter Valve Implantation. This forms goes with the General Cardiology Referral Form and the Lab Requisition for General Cardiology Referral.. ...
Mitral regurgitation (MR) is the second most common valvular heart disease in the western world with a prevalence in the USA alone of two to four million people. MR is age-dependent and hence the MR burden is expected to increase with the increase in life expectancy observed in Europe and the USA. Medical and surgical treatment has been the cornerstone of the treatment as untreated MR results in poor prognosis. However, only a fraction of patients are offered surgical treatment due to high risk. With the success of transcatheter aortic valve implantation (TAVI), many transcatheter options have emerged to provide a less invasive option for these patients ...
BUFFALO, N.Y. - As more elderly patients undergo the minimally invasive heart valve procedure called Transcatheter Aortic Valve Implantation (TAVR), concerns have been raised as to what causes some to be readmitted for heart failure after the procedure.. Now, University at Buffalo researchers, working in the Gates Vascular Institute, Kaleida Health, have published a paper that identifies a new way to predict which patients may be at higher risk.The paper was published online on Aug. 21 in Structural Heart: The Journal of the Heart Team. First author is Aishwarya Bhardwaj, MD, a medical resident in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. Tharmathai Ramanan, MD, clinical cardiovascular disease fellow at UB, is first co-author. Vijay S. Iyer, MD, PhD, associate professor in the UB Department of Medicine, is principal investigator. All see patients through UBMD Internal Medicine.. TAVR is a minimally invasive procedure reserved for patients who have ...
Consultant Cardiologist, University Hospitals of Leicester NHS Trust. Subspecialist in echocardiography, heart failure devices, cardiomyopathy and valve disease. Past-chief examiner, the inaugural British Society of Echocardiography transoesophageal echocardiography examination. Research and publications in contrast echo, resynchronisation therapy, bone marrow stem cell grafting, mitral valve repair, atrial fibrillation ablation, surgical remodelling of the left ventricle, and transcatheter aortic valve implantation.. Other sessions Dr Derek Chin is participating in ...
According to a study published in the January 2014 issue of The Annals of Thoracic Surgery, transcatheter aortic valve implantation (TAVI) is emerging as a
Women undergoing transcatheter aortic valve implantation (TAVI) are generally healthier than their male counterparts and have better survival after the procedure, a single-center study showed.
MIAMI -- Early data from next-generation transcatheter aortic valve implantation (TAVI) devices are promising, but not without safety concerns, researchers reported here at the opening day of the Tran
Computed tomography (CT) provides high, isotropic spatial resolution and has become firmly established in pre-procedural imaging for structural heart disease interventions. It allows determination of the exact dimensions of the target structure, provides information regarding the access route and permits identification of fluoroscopic projection angles to provide optimal visualisation for device placement. Several software solutions are available and have been systematically evaluated in the context of transcatheter aortic valve implantation (TAVI). The use of software products to perform automated measurements can be useful, especially when the experience and expertise regarding evaluation of CT in the context of structural heart disease are limited. In scientific studies, software has been demonstrated to provide accurate support for annulus sizing and prosthesis selection, to aid in reliably identifying patients in whom a transfemoral access may be problematic, and to suggest suitable ...
Hélène Feuillâtre obtained a Masters degree in Computer Science from an engineering school (UTBM - Belfort-Montbéliard University of Technology) and a PhD at the University of Rennes 1. She began to work on the EurValve project in June 2016.. Hélènes main role in EurValve is to develop the Case-Based Reasoning module. In this module, the past experience of physicians is used to solve similar problems. Thanks to similarity measures, The team can retrieve a set of previous cases similar to the current candidate patient from a database. The information provided by these retrieved cases aims to help the practitioner to take the most suitable decision about current case. This relevant information is displayed in a graphical user interface. Currently, they are developing the Case-Based Reasoning module to plan the Transcatheter Aortic Valve Implantation (vascular access and prosthesis choice).. At the moment, the beta version of Case-Based Reasoning module has been integrated into the current ...
Recently, Edwards Lifesciences, a primary heart valve manufacturer, invited more than 60 patients and their caregivers in the heart valve community to Irvine, California, to celebrate Patient Day 2017. This…
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The goal of the study, said investigator Alaide Chieffo, MD (San Raffaele Hospital, Milan, Italy), is to specifically identify what matters most for women undergoing TAVR, as opposed to drawing comparisons with men.. The findings were presented today at EuroPCR and simultaneously published online ahead of print in JACC: Cardiovascular Interventions.. A growing number of studies, including one recently published in Annals of Internal Medicine, have shown a long-term survival advantage for women versus men after TAVR, despite female patients initially having a higher risk of complications.. Device, Patient Characteristics Predict Outcome. For the WIN-TAVI analysis, Chieffo and colleagues studied the 30-day outcomes of 1,019 female patients enrolled at 18 centers across Europe and one in the United States between 2013 and 2015. Mean age was 83 years, and 90% were at high surgical risk. Nearly two-thirds were considered frail. The most commonly implanted valve was the CoreValve prosthesis ...